Balloon Catheter
by Teleflex Medical 4 variants
Ref 331305-000060
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number08019020000000000000254KR 44026704718120 | Date22 Apr 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- 331305-000060
- Primary DI / UDI-DI
- 44026704718120
- Basic UDI-DI
- 08019020000000000000254KR
- EMDN Code
- U010206 Urethral prostatic and bladder catheters, tiemann with balloon
- Device Class
- Class IIa
- EU market of registration
- Ireland
Manufacturer details
- EUDAMED SRN
- IE-MF-000015868
Other devices from Teleflex Medical
Properties
Other properties (11)
- Implantable: No
- Reusable: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No